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CATCH: Tinzaparin reduced recurrent VTE in patients with active cancer
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SAN FRANCISCO — Tinzaparin was associated with a reduced risk for venous thromboembolism without an increase in major bleeding compared with warfarin in a cohort of patients with cancer, according to findings presented at the late-breaker session.
Agnes Y. Y. Lee, MD, of the division of hematology at the University of British Columbia and Vancouver Coastal Health in Canada, said the objective of the CATCH study was to evaluate the efficacy of tinzaparin (Innohep, LEO Pharma) 175 IU/kg once daily in preventing recurrent VTE in patients with active cancer. The researchers also aimed to study the safety of long-term treatment with the drug, to determine the incidence and severity of post-thrombotic syndrome and to identify risk factors and biomarkers for recurrent VTE.
The analysis included 449 patients treated with tinzaparin and 451 patients treated with warfarin. “Approximately 90% of patients completed the study protocol,” Lee said.
The researchers also evaluated for quality-of-life outcomes and use of health care resources associated with the drug.
The protocol dictated that patients have monthly visits with a clinician followed by telephone calls 2 weeks later. “The most common sites of cancer in this patient population were gynecologic, colorectal, upper gastrointestinal and lung,” Lee said.
A composite of symptomatic deep vein thrombosis, symptomatic pulmonary embolism, fatal PE, incidental proximal DVT and incidental proximal PE served as the primary outcome measures. Major bleeding, clinically relevant nonmajor bleeding and overall mortality served as the safety outcomes. The intention-to-treat analysis compared time to the adjudicated first event.
Tinzaparin yielded a risk for recurrent VTE of 7.2% vs. 10.5% for warfarin (HR=0.65; 0.41-1.03). There were 31 thrombosis events in the tinzaparin group and 45 events in the warfarin group.
The drug also significantly lowered the risk for symptomatic DVT by 52% (P=.04), according to Lee. This event occurred in 2.7% of patients in the tinzaparin group and 5.3% of those taking warfarin (HR=0.48; 95% CI, 0.24-0.96).
The drugs were comparable in terms of symptomatic and fatal PE and incidental VTE. According to the per protocol analysis, recurrent VTE occurred in 8.3% of patients receiving tinzaparin and 12.7% of those receiving warfarin (HR=0.62; 95% CI, 0.38-1).
“We did not see an increase in major bleeding with tinzaparin,” Lee said.
Tinzaparin significantly reduced clinically relevant nonmajor bleeding (P=.03). This event was reported in 11.1% of patients in the tinzaparin arm and 16.2% of those in the warfarin arm (HR=0.69; 95% CI, 0.49-0.96).
“There was no difference in overall mortality between the two treatment arms,” Lee said.
For more information:
Lee. Abstract LBA-2. Presented at: ASH Annual Meeting and Exhibition; Dec. 6-9, 2014; San Francisco.
Disclosure: Lee reports associations with Avivia, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Eisai, LEO Pharma, Pfizer and Sanofi-Aventis.
Perspective
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Mary Cushman, MD
This study provides more evidence that low–molecular-weight heparin (LMWH) appears to be superior to warfarin. Not every P value is going to be significant. The effect size was large in the direction you would expect in favor of LMWH preventing occurrence of VTE with no difference in bleeding. On the patient level, you have to decide what is best in terms of a patient’s disease, but also in terms of quality-of-life factors. It is a constant challenge. I see this as another drug in my arsenal.
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